The Center for Molecular Medicine and Immunology (CMMI) requests funds to renovate space for a state-of-the-art Monoclonal Antibody Production Facility for the production of humanized antibodies in support of CMMI's clinical trials. CMMI, established in 1983 and presently located in the City of Newark, New Jersey, is a not-for-profit cancer research and treatment center. To accomplish its long-term goals to be designated as NCI cancer center, CMMI is renovating the former Essex County Isolation Hospital Building of 200,000 gross square feet. In the expanded facility, CMMI has planned 40 to 50 major research laboratories to be centered around a nucleus of 35 senior scientists, with the total staff projected at 300 employees and with nearly 55,000 gsf dedicated to outpatient and inpatient clinical trials. The Monoclonal Antibody Production Facility is intended for the production of cell culture-derived investigational biological agents, principally monoclonal antibodies, to be utilized in clinical trials. This facility will encompass a total area of approximately 10,000 square feet and will have the capability of producing approximately 500 grams of antibody annually. The Production Facility will be constructed, operated, and maintained in accordance with all current Good Manufacturing Practice (cGMPs), as required by the Food and Drug Administration (FDA), and will adhere to all applicable building codes. CMMI's research program, which is the largest continuing program in the field of antibody research, has resulted in over 400 peer-reviewed articles, including the publication of five conferences. To ensure the continuation of CMMI's productivity and leadership role in antibody detection and treatment of cancer, renovation of space for a Monoclonal Antibody Production Facility is an important component of a major CMMI initiative to establish a major clinical cancer center program in the area of biological therapy. Indeed, all of the current NCI-funded investigators have awards in areas of biological therapy, primarily in the use of monoclonal antibodies for radio-immunodetection, radio-immunotherapy and other antibody-targeting methodologies. The Facility will allow the initial scale-up and production of routine and novel biological agents to proceed at an accelerated pace, provide the service necessary for the support of current projects as well as for the expansion of new projects, and most importantly, to allow for maximal patient accrual at the eight community hospitals in CMMI's network in order to determine the efficacy of treatment for Phase II studies, and eventually to benefit patients through Phase III trials.